Head and Neck CancerNCT04872517
Meridian Energy Changes of Head and Neck Cancer Patients After Chemotherapy or Radiotherapy
A study testing Meridian Electroacupuncture Analysis Device (MEAD) in people with Head and Neck Cancer, run by Liao Jian An at 1 site in Taiwan.
Trial summary
This trial is conducted by using MEAD to detect the meridian changes in patients with head and neck cancer after conventional treatment of chemotherapy or radiotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Meridian Electroacupuncture Analysis Device (MEAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with head and neck cancer, included nasopharyngeal carcinoma, laryngeal cancer, oropharyngeal cancer, ear and oral cancer, hypopharyngeal cancer, salivary-gland carcinoma. Aged between 20 years old to 75years old, no gender difference.
- patients with head and neck cancer has not received surgery yet, and will plan to accept chemotherapy and/or radiotherapy.
- recurrent head and neck cancer, and expect to received chemotherapy and/or radiotherapy.
- patient with vital sings stableness, conscious clear, and have ability to recognize the contain of trail and sign consent.
- not accept other adjuvant therapy.
- no brain metastasis or psychosis, and will to join whole course as well as accept assessments.
Who cannot join
- Aged less than 20 years old and over 75 years old。
- Patients be diagnosed with head and neck cancer, and accepted surgery, or already finished chemotherapy and/or radiotherapy.
- patient with brain metastasis, conscious unclear, and have not able to recognize the contain of trail and sign consent.
- Accept other adjuvant therapy and chemotherapy and/or radiotherapy simultaneously.
- Combined with serious organs failure。
- Have contraindication in chemotherapy or radiotherapy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Cung Memorial Hospital
Keelung, 20401
Chao-Hua Fang, 886-2-243-13131 ext. 2501, yihwa0813@yahoo.com.tw
About this study
Official title: Detecting Changes Before and After Chemotherapy or Radiotherapy in Patients With Head and Neck Cancer by Meridian Electroacupuncture Analysis Device (MEAD)
This trial is conducted by using MEAD to detect the meridian changes in patients with head and neck cancer after conventional treatment of chemotherapy or radiotherapy.
Read the detailed description
The purpose of this research is observe the change of meridian energy in patients have be diagnosed with head and neck cancer. The instrument we use is a non-invasive device called meridian energy analysis device(MEAD). The theory of MEAD is use conductive rod to measure the skin resistance from the specific point in human body, and to calculate the meridian's energy change. In Traditional Chinese Medicine theory, physician doctor believe that the median in human body would be affected by disease or uncomfortable condition. So, this time, we who a group of physician of Traditional Chinese medicine department conduct this research to assess the energy change in patients with head and neck cancer. The trail cooperate with radiation oncology department and hematology oncology department. Subject enrollment from radiation oncology department and hematology Oncology department. All of subjects have be diagnosed with head and neck cancer, and will to receive conventional treatment, no matter chemotherapy or/and radiotherapy.
The major assessment of our research is meridian energy by MEAD before treatment, and six consecutive cycles. In addition to this, pain degree, oral mucositis condition, impact on life quality, and blood test, diagnosis imaging data will be collected.
According to G*Power( 3.1.9.4 edition), we expected to recruit 34 subjects. All of Statistical Analysis will use SPSS, pair-t test is used to analyze continuous variable, categorical variable will be analyzed by Chi-Square Test. Multivariate regression analysis will be apply to discuss the major factor of the meridian changes.
MEAD is a kind of non-invasive device, hasn't had adverse effect until now. We will start emergency handling If accidents happened within measurement.
- Conditions
- Head and Neck Cancer
- Being tested
- Meridian Electroacupuncture Analysis Device (MEAD)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meridian Electroacupuncture Analysis Device (MEAD)Device
use MEAD to detect energy change in patient with head and neck cancer
| Study group | Role | What they receive |
|---|---|---|
| 34 head and neck cancer patients, expected to proceed chemotherapy or radiotherapy in hospital. | Experimental | Total 34 anticipants will recruit in this research. Age was limited between 20years old to 75 years old. All of anticipants agree to join this trail and be followed through treatment , and without underlying disease that threaten life. Receives: Device: Meridian Electroacupuncture Analysis Device (MEAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
meridian energy
energy change in meridian
Measured: An average of 6 weeks
Secondary outcomes (5)
the number of participants with blood test data abnormal
calculate the ratio of participants in hemodynamic alteration whom accept chemotherapy or/and radiotherapy, and compare the hemodynamic change with meridian energy change. Blood test include CBC/DC (WBC, RBC, Hemoglobin, Hematocrit, platelets, segment, lymphocyte, absolutely neutrophil), GOT/GPT, Bun/Creatinine, Bilirubin.
Measured: An average of 6 weeks
pain degree
use Numerical Rating Scale(0-10) to assess.
Measured: An average of 6 weeks
Oral mucositis grading
compare enrollment subjects's oral condition with picture from MASCC/ISOO clinical practice guidelines (grade 0-grade 4)
Measured: An average of 6 weeks
adverse impact on quality of life
use EORTC QLQ - H\&N35 questionnaire to evaluate the treatment impact on subject feeling
Measured: An average of 6 weeks
imaging diagnosis
compare tumor condition in diagnostic image data (shrink or progress) with the energy change in meridian.
Measured: An average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This research will use instruction named MEAD to detect the meridian energy before and after chemotherapy or/and radiotherapy. MEAD is a non-invasive device, it will not inter the conventional treatment that conduct by hematology oncology department and radiation oncology department.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liao Jian An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liao Jian An, Chang Gung Memorial Hospital
- Investigators
- Jian-An Liao, Principal investigator, medical attending
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872517
- Sponsor's protocol ID
- 202100209B0C501
- Status last verified
- Sep 2023
- First submitted
- 27 Apr 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Changes Before and After Chemotherapy or Radiotherapy in Patients With Head and Neck Cancer by Meridian Electroacupuncture Analysis Device (MEAD)
- ClinicalTrials.gov ID
- NCT04872517
- Acronym / sponsor ID
- 202100209B0C501
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Liao Jian AnUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted by using MEAD to detect the meridian changes in patients with head and neck cancer after conventional treatment of chemotherapy or radiotherapy.
Detailed description
The purpose of this research is observe the change of meridian energy in patients have be diagnosed with head and neck cancer. The instrument we use is a non-invasive device called meridian energy analysis device(MEAD). The theory of MEAD is use conductive rod to measure the skin resistance from the specific point in human body, and to calculate the meridian's energy change. In Traditional Chinese Medicine theory, physician doctor believe that the median in human body would be affected by disease or uncomfortable condition. So, this time, we who a group of physician of Traditional Chinese medicine department conduct this research to assess the energy change in patients with head and neck cancer. The trail cooperate with radiation oncology department and hematology oncology department. Subject enrollment from radiation oncology department and hematology Oncology department. All of subjects have be diagnosed with head and neck cancer, and will to receive conventional treatment, no matter chemotherapy or/and radiotherapy.
The major assessment of our research is meridian energy by MEAD before treatment, and six consecutive cycles. In addition to this, pain degree, oral mucositis condition, impact on life quality, and blood test, diagnosis imaging data will be collected.
According to G*Power( 3.1.9.4 edition), we expected to recruit 34 subjects. All of Statistical Analysis will use SPSS, pair-t test is used to analyze continuous variable, categorical variable will be analyzed by Chi-Square Test. Multivariate regression analysis will be apply to discuss the major factor of the meridian changes.
MEAD is a kind of non-invasive device, hasn't had adverse effect until now. We will start emergency handling If accidents happened within measurement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This research will use instruction named MEAD to detect the meridian energy before and after chemotherapy or/and radiotherapy. MEAD is a non-invasive device, it will not inter the conventional treatment that conduct by hematology oncology department and radiation oncology department.
| Arm | Type | Receives |
|---|---|---|
| 34 head and neck cancer patients, expected to proceed chemotherapy or radiotherapy in hospital. | Experimental | Device: Meridian Electroacupuncture Analysis Device (MEAD)Total 34 anticipants will recruit in this research. Age was limited between 20years old to 75 years old. All of anticipants agree to join this trail and be followed through treatment , and without underlying disease that threaten life. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with head and neck cancer, included nasopharyngeal carcinoma, laryngeal cancer, oropharyngeal cancer, ear and oral cancer, hypopharyngeal cancer, salivary-gland carcinoma. Aged between 20 years old to 75years old, no gender difference.
- patients with head and neck cancer has not received surgery yet, and will plan to accept chemotherapy and/or radiotherapy.
- recurrent head and neck cancer, and expect to received chemotherapy and/or radiotherapy.
- patient with vital sings stableness, conscious clear, and have ability to recognize the contain of trail and sign consent.
- not accept other adjuvant therapy.
Key exclusion criteria (6 listed)
- Aged less than 20 years old and over 75 years old。
- Patients be diagnosed with head and neck cancer, and accepted surgery, or already finished chemotherapy and/or radiotherapy.
- patient with brain metastasis, conscious unclear, and have not able to recognize the contain of trail and sign consent.
- Accept other adjuvant therapy and chemotherapy and/or radiotherapy simultaneously.
- Combined with serious organs failure。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meridian Electroacupuncture Analysis Device (MEAD)use MEAD to detect energy change in patient with head and neck cancer | Device | 34 head and neck cancer patients, expected to proceed chemotherapy or radiotherapy in hospital. |
Primary outcome
meridian energy
Time frame: An average of 6 weeks
energy change in meridian
5 secondary outcomes
the number of participants with blood test data abnormal
Time frame: An average of 6 weeks
pain degree
Time frame: An average of 6 weeks
Oral mucositis grading
Time frame: An average of 6 weeks
adverse impact on quality of life
Time frame: An average of 6 weeks
imaging diagnosis
Time frame: An average of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-An Liao principal investigator
medical attending
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meridian Electroacupuncture Analysis Device (MEAD) in people with Head and Neck Cancer, run by Liao Jian An at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Hua Fang (886-2-24313131 ext. 2501, yihwa0813@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meridian energy (time frame: An average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.